16 Sep Efficacy of an Ayurvedic Formulation for Mild-to-moderate Osteoarthritis: A Phase 3, Randomized Controlled Study.
Current treatment options offer only symptomatic pain relief for patients with osteoarthritis (OA). Thus, a need exists for effective treatment of the disability-causing disease.
Objective • The study intended to compare the benefits of the herbal formulation with those of routinely used NSAIDs for patients with mild-to-moderate OA. Design • A phase 3, double-blind, double-dummy, randomized controlled study. Setting • Outcome Measures • To measure efficacy, the study used the modified Center for Rheumatic Diseases Pune version of the Western Ontario and McMaster Universities OA index (WOMAC) and the Health Assessment Questionnaire (HAQ).
The combined WOMAC scores were significantly reduced from baseline to postintervention for both groups (P < .01). The earliest significant reduction was seen at week 4 (P < .01) and persisted at subsequent visits (P < .01). Similar changes were also seen in the WOMAC subscales-pain, stiffness, and physical function or difficulty in performing routine activities-and HAQ scores. Similar changes were also seen in the WOMAC subscales-pain, stiffness, and physical function or difficulty in performing routine activities-and HAQ scores. Improvement was also observed with perceived pain relief. Overall, the efficacy of the herbal formulation was not inferior to the diclofenac.
Conclusions • For patients with mild-to-moderate OA, Nartana significantly reduced joint pain, stiffness, and physical function; improved quality of life; and provided pain relief. The herbal formulation’s efficacy was not inferior to routinely prescribed diclofenac. The drug should be explored further in large long-term comparative studies as an alternative to NSAIDs.